News Digest 02.08.2024 — 05.08.2024
Regulators
Roszdravnadzor has published sample notifications on the start of clinical trials of medical devices, including software, for registration under the rules of the EAEU.
Source: https://t.me/vademecum_ru/5419
Document: https://roszdravnadzor.gov.ru/documents/84605
Market news
Murashko sent a medical train to remote regions
Minister of Health Mikhail Murashko and CEO of Russian Railways Oleg Belozerov presented a mobile clinical diagnostic center (MCDC) - the medical train "Saint Panteleimon" - at the Yaroslavsky railway station in Moscow on August 2. It is designed to provide medical care to patients in remote areas of the country, the press service of Russian Railways reported.
This is the first train registered by Roszdravnadzor as a medical device. It consists of 14 cars, eight of which are equipped with medical equipment for radiation and functional diagnostics, therapeutic and surgical care. Patients of the mobile clinic will have the opportunity to have X-rays, mammograms, ultrasounds, undergo spirometry and stress tests, and receive consultations from an endocrinologist, urologist, surgeon, pediatrician, and geriatrician.
Another six cars are auxiliary - intended for accommodation of medical personnel. More than 90 employees of "RZhD-Medicine" work in the mobile clinic, including 72 doctors, as well as mid-level and junior medical personnel.
The train's route will pass through eight regions: the republics of Buryatia and Sakha (Yakutia), the Trans-Baikal, Primorsky, and Khabarovsk territories, the Amur, Irkutsk, and Jewish Autonomous Regions. The mobile clinic will visit 59 settlements, and its crew is expected to provide medical care to 180 thousand adults and 37 thousand children.
Source: https://medvestnik.ru/content/news/Murashko-otpravil-v-otdelennye-regiony-medicinskii-poezd.html
Russians purchased rehabilitation equipment using an electronic certificate for 17 billion rubles
Since the beginning of 2024, Russians with disabilities have purchased technical rehabilitation equipment (TRE) through an electronic certificate for more than 17 billion rubles. This was reported by the Minister of Labor and Social Protection of the Russian Federation Anton Kotyakov during a working trip to the Kaliningrad Region, noting the growing demand for this method of providing TRE.
"The mechanism of the electronic certificate - the popularity of this tool is growing, and now almost 50% of funds are sent through this method of providing technical rehabilitation equipment. Since the beginning of the year, over 17 billion rubles have already been transferred using electronic certificates," he said.
Kotyakov noted that currently wheelchairs produced in the Kaliningrad Region make up more than a third of the total number of electric wheelchairs purchased by the Social Fund of Russia.
During the visit, the minister discussed issues of allocating funds for the construction of additional rehabilitation infrastructure facilities in the region. "We agreed that we will begin construction of a social hospital for the elderly. There are good standard designs for modern institutions - this is apartment-type accommodation, opportunities for creativity, leisure. We will provide the region with standard designs in order to reduce the time for developing design and estimate documentation and start next year," he specified.
Source: https://tass.ru/obschestvo/21523219
Other
Sberbank has developed an AI service for assessing heart studies
Sberbank's Artificial Intelligence Laboratory, together with Sberbank's Health Industry Center and the Laboratory of X-ray Endovascular Diagnostics and Treatment Methods of the Tyumen Cardiology Research Center (branch of the Tomsk National Research Medical Center of the Russian Academy of Sciences), presented a solution for automating the calculation of the SYNTAX score (a method for assessing the severity of damage in ischemic heart disease) based on coronary angiography video files.
The AI model helps doctors better understand coronary angiography results and make informed treatment decisions. However, the system operates in information and reference mode. It is noted that the model can be useful as a second opinion. Patients and doctors can independently download the study on the website of the Tyumen Cardiology Research Center.
Source: https://t.me/vademecum_live/15171
A more effective foot prosthesis mimics the bones of a real foot
Created by Manuel G. Catalano and colleagues from the Istituto Italiano di Tecnologia (Italian Institute of Technology), the prototype device is completely unpowered and weighs only 450 g (1 lb). It can withstand a load of up to 100 kg (220 lb) per user.
SoftFoot Pro includes five parallel chains of linked high-strength plastic segments. The anterior segments of each chain mimic the phalanges (bones of the toes), and the segments behind them mimic the metatarsal bones (which run from the base of each toe to the heel).
Elastic connectors are used to connect the segments of each chain. An internal steel cable runs the length of each chain and is attached to a titanium heel. Above the five chains is a titanium arch mechanism. One end of it is connected to the base of the phalanges, and the other to the heel. Both connection points allow the phalanges and heel to rotate relative. This setup serves the same function as the plantar fascia of the human foot, which is a band of tissue that connects the heel bone to the base of the toes.
Like the plantar fascia of the foot, the arch mechanism allows the SoftFoot Pro to store energy as the toes flex at the end of each step, and then release that energy as the foot leaves the ground to take the next step forward. When the prosthesis hits the ground, its flexible design reportedly allows it to absorb between 10% and 50% of the impact energy.
The SoftFoot Pro additionally allows the toes to flex relative to the rest of the foot when climbing slopes, keeping the user upright, and it also adjusts to uneven surfaces, preventing the user from toppling over. The device also makes it easier to perform actions like kneeling or squatting, and since it is water-resistant, it can be used in a variety of outdoor activities. Volunteers with amputations have already tested SoftFoot Pro in clinical trials conducted at the Hannover Medical School and the Medical University of Vienna. And in recognition of other potential uses for the technology, it has also been tested on the Anymal quadruped robot at ETH Zurich and the HRP-4 humanoid robot at the University of Tokyo.
Source: https://newatlas.com/good-thinking/softfoot-pro-prosthetic-foot/
Second person successfully implanted with Neuralink implant
Elon Musk announced the successful implantation of Neuralink's Telepathy implant in the brain. The implant was received by a second volunteer. According to Musk, everything works "very well."
Neuralink received approval from the US Food and Drug Administration (FDA) to conduct human neurochip CI in May 2023. In late January of this year, it reported the first successful implantation of a chip in the human brain. Elon Musk noted that patient Nolan Arbo was able to use the device to control a computer mouse and later play chess.
Arbo noted that despite the fact that some of the electrodes had previously come loose from the brain, the device's efficiency was only growing. According to Arbo, "plus or minus 15%" is currently working. He believes that if the next participant in the experiment can get all 100% or 90% of the electrode threads working, "he will be able to do what I can't do now, and that gives great hope for the future."
Elon Musk clarified that the company hopes to increase the number of patients with Neuralink implants to 10 by the end of the year.
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